Platform for assessing molecular testing and treatment outcomes in lung cancer patients

Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients

This study is trying to gather and analyze information about treatments and outcomes for people with lung cancer to improve care and understand their quality of life better.

Quick facts

• Study type: Observational
• Enrollment: 12400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AIO-Studien-gGmbH (other)
• Drugs / interventions: radiation
• Locations: 1 site (Oldenburg)
• Trial ID: NCT02622581 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a national clinical research platform in Germany to document and analyze data on molecular biomarker testing, treatment, and outcomes for patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). It focuses on collecting uniform data from real-life practice to evaluate the quality of care and develop recommendations for improvement. The study will also assess quality of life and mental health aspects of patients through validated questionnaires, and establish a tissue repository for future research.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed metastatic or advanced non-small cell lung cancer or small cell lung cancer.

Not a fit: Patients with early-stage lung cancer who are not receiving systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of treatment effectiveness and improve care strategies for lung cancer patients.

How similar studies have performed: Other studies focusing on molecular testing and real-world outcomes in lung cancer have shown promise, indicating that this approach is supported by previous research.

Eligibility criteria

Inclusion Criteria:

Patients who meet all of the following criteria are eligible for the project:

* Age ≥ 18 years
* Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments

Main project (Metatstatic NSCLC):

* Confirmed non-small cell lung cancer (NSCLC)
* Informed consent no later than four weeks after start of first-line systemic treatment or no later than four weeks after diagnosis for patients receiving "best supportive care only"
* Stage IV, or stage IIIB/C (UICC8) if patient is ineligible for curative surgery and/or radiochemotherapy
* Systemic therapy or best supportive care

Satellite Stage I/II/III (NSCLC):

* Confirmed non-small cell lung cancer (NSCLC)
* Informed consent no later than four weeks after start of first anti-tumor treatment (including surgery and radiotherapy) or no later than four weeks after diagnosis for patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)
* Stage I, Stage II, stage IIIA, or stage IIIB/C (UICC8)
* Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive care

Satellite SCLC

* Confirmed Small cell lung cancer (SCLC)
* Informed consent no later than four weeks after start of first anti-tumor treatment or no later than four weeks after diagnosis for patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)
* Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive care

Exclusion Criteria:

none

Where this trial is running

Oldenburg

• Pius-Hospital — Oldenburg, Germany (RECRUITING)

Study contacts

• Principal investigator: Frank Griesinger, Prof. Dr. — Pius-Hospital Oldenburg
• Study coordinator: Annika Groth

Conditions: Metastatic Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage II, Non Small Cell Lung Cancer Stage III, Small-cell Lung Cancer, Non-small Cell Lung Cancer Stage I